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SUNAYANA MOTWANI

Regulatory Affairs-HealthCare and Life Sciences

+601********* Kuala Lumpur, Malaysia

acwg6q@r.postjobfree.com sunayana-motwani-78764235 CAREER ABSTRACT

A versatile and experienced regulatory affairs professional backed up with a background of Biotechnology and Clinical Research (current-online courses) academically.

Have hands on experience in preparation, review, submission of preapproval and post approval regulatory documents for generics-API and Formulations (Parenteral- Injectables as well as oral solid dosage forms).I have also worked in Corporate Quality Assurance, Audit compliance and have been involved in Audit support team for regulatory audits/ GMP Inspections like USFDA,MHRA and other Client audits.

Successfully registered pharmaceutical products to TGA and Medsafe.

Well versed with product life cycle management for countries Australia,Newzealand, South Africa, Health Canada and Europe.

Provided regulatory advice in relation to product developments, change control requests, market complaints, deviations and planned changes and providing pragmatic solutions to issues as they arise.

CORE SKILLS

Regulatory Knowledge: Well versed with GMP, GCP,GDP, ICH,TGA Guidance and regulations.

Good understanding of Management systems (QMS).

Software Skills: Proficient in MS Office, Outlook, Adobe Professional.

Strong presentation, communication, documentation, and interpersonal skills.

Ability to handle multiple tasks to meet deadlines, delivering high quality work in a dynamic environment.

Strong personal integrity and customer focus.

ACHIEVEMENTS

Appreciated twice by Claris Management team for “GoodJob”. a) Cleared backlog of review of Product batch documents (GMP BMR/BPR) well within the expected timeframe for product release in Europe which also was appreciated by clients. This activity saved time for continuous sales in EU Region. b) Reviewed and responded to client product queries promptly so that the product gets submitted to TGA at the earliest and ensured smooth query resolving procedure in company by interacting with various departments.

Developed Regulatory strategy at Alembic for submitting post approval changes to TGA of one product and multiple clients scenario which proved beneficial to clients.

Supported cross functional team members of QA and CQA during GMP Inspection and verifying Page 2

compliances.

Reviewed SOPs and submitted gap analysis to management for better and systematic procedures in place.

Due to my hard work, I was promoted as youngest Team Leader (handled ORM Territory with a team of 4) in Claris RA Team and additional markets were added to my belt in short time.

Initiated the project of Communication of critical change controls to clients. WORK EXPERIENCE

I. Alembic Pharmaceutical Ltd (Dosage-Solid Orals) June 2014- Feb 2016 Corporate Regulatory Affairs Executive

To handle regulatory requirements through product lifecycle both in preapproval as well as post approval stage with core focus in CMC for countries Australia and Europe.

Provided support to Marketing/Business team for product launch activities and dynamically participates in regulatory strategy/intelligence.

Audit and Compliance: To carry out internal audits quality systems and facilities as per ICHQ7 and reporting to site head/Regulatory head for the same.

Responsible for quality review of SOP.

II.Claris Lifesciences Ltd/ (Dosage- Injectables) Dec- 2011 – May 2014 International Regulatory Affairs & Corporate Quality Assurance (Post Approval Compliances)

Handled all drug registration activities- Dossier submissions, query handling and Variation submissions.

Handled communications with company's associates, partners, regulatory assessors through emails and tele-conferences from regulatory affairs point of view.

Worked for all Regulated Markets like Australia, Canada, South Africa, New Zealand including Europe region.

Preparation & Review of Technical Agreement in for various geographical regions.

To review & share key update to partner such as Annual Product Reviews (APRs), stability data, deviation reports & also method transfers of new products to Partner/QP.

Monitor the regulatory compliance of all the approved products.

Assisted in internal and external audits and inspections, market complaints and its investigation.

To be involved in product development and discuss marketing strategy for its launch in specific country.

Review of GMP Batch documents for product release in EU Region.

Review and approve all labeling materials to ensure regulatory compliance. III.Ami Lifesciences Ltd/ (API )June-Dec 2011

Quality Assurance Department/Regulatory Affairs-Trainee-

Preparing Drug Master File (DMF), To coordinate with Unit Quality Assurance, Quality Control, Packing, Stores Department and R & D department for data generation for Drug Master Files

Review of Vendor documents for its completeness and filing of documents.

Assist to QMS team for investigations and documentation. Page 3

THESIS

DISSERTATION WORK-Veterinary College, Anand Agriculture University,Anand. Project: SNP genotyping of Growth Hormone Receptor (GHR) gene & its association with milk yield & milk fat percentage. Hands on experience-DNA,RNA & protein Extraction from various sources, Thermo cycler, RFLP,RAPD,SSCP/PAGE, Sanger Sequencing, Spectrophotometer & nanodrop,Electrophoresis,all types of centrifuge, Sequence Analysis Software’s: SeqScape v 2.5& Sequence Analysis v 5.

EDUCATION

MSc.Biotechnology 2011 (65.04%)

ARIBAS-Sardar Patel University, Vidyanagar,Gujarat,INDIA

BSc.Biotechnology/2009 (59%)

P.M.Patel- Sardar Patel University, Vidyanagar, Gujarat,INDIA

Designs & Interpretation of Clinical Trials Coursera (Online) –May 2016

IELTS SCORE-7/9

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